U.S. Medical Device Regulation QA

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Email: hou4ww@evershinecpa.com

Or contact by phone in the Texas time zone:
The Engaging Manager Ian Lin, a well-English speaker
Tel: +1-510-996-2685

HLF-TW-10

What are the categories of medical devices in U.S.? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of medical devices? Website?

Evershine RD：

Per Section 201(h) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
2.  intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
3. intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
The term “device” does not include software functions excluded pursuant to section 520(o).

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels.
Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:

Device Class and Regulatory Controls

1. Class I General Controls

2. Class II General Controls and Special Controls

3. Class III General Controls and Premarket Approval

In addition, classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.

【Website】

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

HLF-TW-20

If a foreign company wants to sell medical devices in U.S., no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?

Evershine RD：

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.
Information about a foreign establishment’s U.S. Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent.
The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent.
The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.

【Website】

https://www.fda.gov/medical-devices/device-registration-and-listing/us-agents

HLF-TW-30

If a foreign company wants to sell medical devices in U.S., can it assign a U.S.ese company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?

Evershine RD：

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.Information about a foreign establishment’s U.S.
Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent.
The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent.
The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.

Foreign Manufacturers of Medical Devices

A foreign manufacturer is a manufacturer located outside of the United States. Foreign manufacturers must meet applicable U.S. regulations in order to import a device into the U.S.

The basic regulatory requirements include:

• Establishment registration
• Medical Device Listing
• Quality System
• Premarket Notification [510(k)], unless exempt, or Premarket Approval
• Labeling
• Medical Device Reporting.

A foreign manufacturer must designate a United States agent as a part of its initial and updated registration information. A foreign manufacturing site is subject to FDA inspection, medical device tracking (when required), and adverse event reporting.

Initial Importers of Medical Devices

An initial importer is defined in Title 21 Code of Federal Regulations (21 CFR) Part 807.3(g) as any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.
An initial importer of a medical device is required to comply with the following regulatory requirements:

• Establishment registration
• Medical Device Reporting (MDR) (21 CFR 803)
• Reports of Corrections and Removals (21 CFR 806)
• Medical Device Tracking (21 CFR 821), where applicable.

Under the MDR regulations, an importer is required to report incidents in which a device may have caused or contributed to a death or serious injury as well as certain malfunctions. An importer must maintain an MDR event file for each adverse event.
All product complaints including MDR and non MDR events, must be forwarded to the manufacturer.
Under the Medical Device Tracking regulation, certain devices must be tracked through the distribution chain.

Responsibilities of a U.S. agent

The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S.
The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service.
They must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the U.S. agent are limited and include:
assisting FDA in communications with the foreign establishment,
responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States,
assisting FDA in scheduling inspections of the foreign establishment and

if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

【Website】

https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/importing-medical-devices-and-radiation-emitting-electronic-products-us

https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/importing-medical-devices-and-radiation-emitting-electronic-products-us#process

https://www.fda.gov/media/82395/download

https://www.fda.gov/medical-devices/device-registration-and-listing/us-agents

HLF-TW-40

Do foreign companies need to apply for an approval before importing medical devices sold to U.S.?
If yes, which authority is in charge? What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval?
In addition to English, which other languages ​​are allowed? Website?

Evershine RD：

The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market.

If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing.
All devices classified as exempt are subject to the limitations on exemptions.
For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA’s have not been called for. In that case, a 510k will be the route to market.

The Abbreviated 510(k) Program uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA’s premarket review of 510(k) submissions.
The alternative approach described in this guidance document is intended to facilitate 510(k) submission preparation by manufacturers and review by FDA.
FDA believes this voluntary program may conserve industry and Agency resources, while still protecting the public health, and not altering the statutory criteria for substantial equivalence.

For the current edition of the FDA-recognized standard(s), see the FDA Recognized Consensus Standards Database. (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm)

General Labeling Provisions

The general labeling requirements for medical devices are contained in 21 CFR Part 801.
These regulations specify the minimum requirements for all devices.
Later sections in this chapter discuss any additional requirements needed for specific categories of devices.

Name and Place of Business

• The label of a device shall contain the name and place of business of manufacturer, packer, or distributor including the street address, city, state, and zip code.
• If the firm’s street address is in the local telephone directory, the street address can be omitted.
• If the firm listed on the label is not the manufacturer, the firm information must be qualified by an appropriate statement such as, “Manufactured for…” or “Distributed by….”

Intended Use 

• If a packer, distributor, or seller intends a device for uses other than those intended by the person from whom he received the device, these parties must furnish adequate labeling in accordance with the new intended use.
• If a manufacturer knows or has information indicating that this device is to be used for conditions or purposes other than which it was intended, he is required to provide adequate labeling in accordance with such other uses. (An example of this might be a manufacturer of dental X-ray equipment who is routinely selling his product to podiatrists.)

Adequate Directions 

• “Adequate directions for use” means directions under which the layman can use a device safely and for the purposes intended. This includes:
  • Statements of all purposes for which and conditions under which the device can be used;
  • Quantity of dose for each use and usual quantities for persons of different ages and physical conditions;
  • Frequency of administration;
  • Duration of application;
  • Time of administration in relation to other factors;
  • Route or method of application; and
  • Any preparation necessary for use.

False or Misleading Statements 

• A device is misbranded if it makes a false or misleading statement with respect to another device, drug, food, or cosmetic.

Prominence of Statements

• A word, statement or other required information may lack the required prominence and conspicuousness for the following reasons:
  • If it fails to appear on the part or panel that is displayed under customary conditions of purchase;
  • If the package contains sufficient space and the required information fails to appear on two or more panels, each of which is designed to render it to be displayed under customary conditions of purchase;
  • Failure to extend required labeling over package space provided;
  • Lack of sufficient label space for required labeling due to placement of non-required labeling of the package; or
  • Smallness or style of type, insufficient contrast between labeling and package background, designs which obscure labeling, or overcrowding of labeling shich renders it unreadable.

Exemptions

• Exemptions may be granted in those instances where device labeling lacks sufficient space for required labeling provided that:
  • Existing label space is not taken up by including non-required information or by giving prominence to a portion of the required labeling; and
    Existing label space is not used for any representations in a foreign language.
    All labeling shall be in English with the exception of products distributed solely within Puerto Rico or a U.S. territory where the predominant language is other than English. In these instances the predominant language may be substituted for English.
  • If any representation on the device label or labeling appears in a foreign language, then all required labeling shall also appear in that foreign language.

【Website】

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements

HLF-TW-50

Can a foreign company apply for a product license by its own name?
If yes, which authority is in charge? What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval?
In addition to English, which other languages ​​are allowed? Website?

Evershine RD：

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.

Information about a foreign establishment’s U.S. Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process.
Each foreign establishment may designate only one U.S. agent.
The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent.
The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.

The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market.
If your device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing.
All devices classified as exempt are subject to the limitations on exemptions. For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, or substantially equivalent to such a device) and PMA’s have not been called for.
In that case, a 510k will be the route to market.

The Abbreviated 510(k) Program uses guidance documents, special controls, and/or voluntary consensus standards to facilitate FDA’s premarket review of 510(k) submissions.
The alternative approach described in this guidance document is intended to facilitate 510(k) submission preparation by manufacturers and review by FDA.
FDA believes this voluntary program may conserve industry and Agency resources, while still protecting the public health, and not altering the statutory criteria for substantial equivalence.

For the current edition of the FDA-recognized standard(s), see the FDA Recognized Consensus Standards Database. (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm)

General Labeling Provisions

The general labeling requirements for medical devices are contained in 21 CFR Part 801.
These regulations specify the minimum requirements for all devices.
Later sections in this chapter discuss any additional requirements needed for specific categories of devices.

Name and Place of Business

• The label of a device shall contain the name and place of business of manufacturer, packer, or distributor including the street address, city, state, and zip code.
• If the firm’s street address is in the local telephone directory, the street address can be omitted.
• If the firm listed on the label is not the manufacturer, the firm information must be qualified by an appropriate statement such as, “Manufactured for…” or “Distributed by….”

Intended Use 

• If a packer, distributor, or seller intends a device for uses other than those intended by the person from whom he received the device, these parties must furnish adequate labeling in accordance with the new intended use.
• If a manufacturer knows or has information indicating that this device is to be used for conditions or purposes other than which it was intended, he is required to provide adequate labeling in accordance with such other uses. (An example of this might be a manufacturer of dental X-ray equipment who is routinely selling his product to podiatrists.)

Adequate Directions 

• “Adequate directions for use” means directions under which the layman can use a device safely and for the purposes intended. This includes:
  • Statements of all purposes for which and conditions under which the device can be used;
  • Quantity of dose for each use and usual quantities for persons of different ages and physical conditions;
  • Frequency of administration;
  • Duration of application;
  • Time of administration in relation to other factors;
  • Route or method of application; and
  • Any preparation necessary for use.

False or Misleading Statements 

• A device is misbranded if it makes a false or misleading statement with respect to another device, drug, food, or cosmetic.

Prominence of Statements

• A word, statement or other required information may lack the required prominence and conspicuousness for the following reasons:
  • If it fails to appear on the part or panel that is displayed under customary conditions of purchase;
  • If the package contains sufficient space and the required information fails to appear on two or more panels, each of which is designed to render it to be displayed under customary conditions of purchase;
  • Failure to extend required labeling over package space provided;
  • Lack of sufficient label space for required labeling due to placement of non-required labeling of the package; or
  • Smallness or style of type, insufficient contrast between labeling and package background, designs which obscure labeling, or overcrowding of labeling shich renders it unreadable.

Exemptions

• Exemptions may be granted in those instances where device labeling lacks sufficient space for required labeling provided that:
  • Existing label space is not taken up by including non-required information or by giving prominence to a portion of the required labeling; and
    Existing label space is not used for any representations in a foreign language.
    All labeling shall be in English with the exception of products distributed solely within Puerto Rico or a U.S. territory where the predominant language is other than English.
    In these instances the predominant language may be substituted for English.
  • If any representation on the device label or labeling appears in a foreign language, then all required labeling shall also appear in that foreign language.

【Website】

https://www.fda.gov/medical-devices/device-registration-and-listing/us-agents

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements

HLF-TW-60

What are the required documents for the application of importing medical devices registration?
What is the application process? Website?

Evershine RD：

All medical devices imported into the United States (U.S.) must meet the regulatory requirements of both the U.S. Bureau of Customs and Border Protection (CBP) and FDA.
Products that do not meet FDA regulatory requirements may be detained upon entry.

CBP administers the Tariff Act of 1930 as amended. The primary duties include: assessment and collection of all duties, taxes, and fees on imported merchandise, administering and reviewing import entry forms, enforcing CBP and related laws, and administering certain navigation laws and treaties. 
FDA and CBP have an agreement for the cooperative enforcement of the Food, Drug, and Cosmetic Act, Section 801, Title 21 U.S.C. 381.

An entry for an FDA regulated product that is filed with CBP, will also be electronically submitted to FDA for review.
An importer or customs broker is required to submit required entry information to CBP through the Automated Commercial Environment (ACE) system.

The required entry information includes:

•   country of origin

•   importation product code, which is a combination of the FDA panel code and FDA product code

•   importer product description

•   manufacturer

•   shipper

•   applicable affirmations of compliance codes

•   Harmonized Tariff Schedule (HTS) code for the product described in the importing documents.

【Website】

https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/importing-medical-devices-and-radiation-emitting-electronic-products-us#process

HLF-TW-70

What are the laboratory inspection materials that need to be attached for TFDA verification?

Evershine RD：

The category and type of medical device to which it belongs determines the content of the application documents required.
Please refer to 510(k) and PMA regulations according to the type of medical device.

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA.
Only a small percentage of 510(k)s require clinical data to support the application.
Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices.
All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
Clinical evaluation of devices that have not been cleared for marketing requires:

• an investigational plan approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by FDA;
• informed consent from all patients;
• labeling stating that the device is for investigational use only;
• monitoring of the study and;
• required records and reports.

【Website】

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide

HLF-TW-80

After a foreign subsidiary imports medical devices and entrusts a distributor in U.S. to sell it, does the distributor need a medical devices business license?
What are the respective responsibilities of foreign subsidiaries and distributors if medical devices products have quality defects?
Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?

Evershine RD：

A foreign manufacturer must designate a United States agent as a part of its initial and updated registration information.
A foreign manufacturing site is subject to FDA inspection, medical device tracking (when required), and adverse event reporting.

Under the MDR regulations, an importer is required to report incidents in which a device may have caused or contributed to a death or serious injury as well as certain malfunctions.
An importer must maintain an MDR event file for each adverse event.
All product complaints including MDR and non MDR events, must be forwarded to the manufacturer.
Under the Medical Device Tracking regulation, certain devices must be tracked through the distribution chain.

The responsibilities of the U.S. agent are limited and include: assisting FDA in communications with the foreign establishment, responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States, assisting FDA in scheduling inspections of the foreign establishment and if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

【Website】

https://www.fda.gov/medical-devices/device-registration-and-listing/us-agents

https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/importing-medical-devices-and-radiation-emitting-electronic-products-us#process

Contact Us

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E-mail: hou4ww@evershinecpa.com
or
Contact by phone in the Texas time zone:
The Engaging Manager Ian Lin, a well-English speaker
Tel: +1-510-996-2685
or
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Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable for your case.
Email address:dalechen@evershinecpa.com
LinkedIn address: Dale Chen

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Email: kerrychen@evershinecpa.com
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(version: 2024/07)